|Publication number||US8011366 B2|
|Application number||US 11/035,124|
|Publication date||Sep 6, 2011|
|Priority date||Feb 4, 2004|
|Also published as||US20050166922|
|Publication number||035124, 11035124, US 8011366 B2, US 8011366B2, US-B2-8011366, US8011366 B2, US8011366B2|
|Inventors||Michael B. Knepper|
|Original Assignee||Devilbiss Healthcare Llc|
|Export Citation||BiBTeX, EndNote, RefMan|
|Patent Citations (8), Referenced by (20), Classifications (11), Legal Events (9)|
|External Links: USPTO, USPTO Assignment, Espacenet|
Applicants claim priority to U.S. Provisional Patent Application Ser. No. 60/541,792 filed Feb. 4, 2004.
The invention relates to a method for acclimating a patient to CPAP therapy when the CPAP apparatus is first turned on and the patient has not yet fallen asleep.
The application of a continuous positive airway pressure (CPAP) to a patient's respiratory system is a frequently used therapy for treating sleep disorders such as obstructive sleep apnea. Typically, positive air pressure is applied to the patient's airway through either a nasal mask or a nasal cannula. Apnea is commonly caused by the upper airway being blocked or collapsing during sleep. With CPAP, an inspiratory positive airway pressure (IPAP) applied to the patient is set to a pressure which expands or inflates the airway sufficiently to prevent its blockage during inspiration. The lowest effective IPAP pressure for a patient may be determined through titration in a sleep clinic or by using CPAP apparatus which is programmed to automatically adjusts the applied pressure up and down in response to the occurrence and the absence of sleep events until the events cease. The pressure is increased and decreased while monitoring for abnormal sleep events until the lowest effective IPAP pressure is determined.
CPAP therapy is effective only so long as the patient complies with the prescribed therapy. As many as 20% to 40% of the patients for which CPAP therapy is prescribed fail to adhere to the prescribed therapy due to discomfort. The most frequent source of discomfort is with the nasal mask. A second source of discomfort can result from the additional work of breathing against the applied CPAP pressure. This is particularly noticeable when the CPAP pressure is first applied while the patient is still awake. Inspiration is not a problem with a positive airway pressure. However, there is additional effort in exhaling against the positive airway pressure. One solution for reducing discomfort has been to provide the CPAP apparatus with a soft start. When the apparatus is initially turned on, a relative low positive pressure is applied to the patient's airway. This pressure is below the prescribed pressure necessary for preventing abnormal respiratory events. However, abnormal respiratory events are generally not a problem while the patient is awake. Over a programmed period of time such as 20 or 30 minutes, the applied pressure is gradually increased or ramped up to the prescribed therapeutic pressure. Some CPAP apparatus provides a constant low pressure for a period of time prior to increasing to the prescribed therapeutic pressure. The soft start helps the patient to fall asleep before the pressure is increased to the therapeutic level.
For standard CPAP apparatus, the IPAP pressure and the expiratory positive airway pressure (EPAP) are substantially the same. Another method for reducing discomfort from exhaling against the therapeutic pressure is to provide bilevel CPAP therapy. For obstructive sleep apnea, most airway blockages occur only during inspiration. In a bilevel system, the CPAP apparatus is controlled to increase the applied IPAP pressure to the prescribed therapeutic level in response to sensing the beginning of inspiration and to decrease the applied EPAP pressure to a lower, more comfortable level in response to sensing the beginning of expiration. This reduces the effort and discomfort of exhaling against the prescribed pressure. Bilevel CPAP therapy is particularly useful for patients who require a high IPAP pressure for preventing abnormal sleep events. However, for some patients, bilevel CPAP therapy may not be as effective as applying a constant therapeutic pressure to the patient.
The invention is directed to a method for acclimating a CPAP therapy patient to the prescribed pressure during the time the patient is falling asleep. When the CPAP apparatus is first turned on, a bilevel positive pressure is applied to the patient's respiratory system. The pressure alternates between an IPAP pressure set at the patient's prescribed therapeutic pressure when the patient inhales and a predetermined low EPAP pressure when the patient exhales. After a programmed delay, the EPAP pressure is gradually increased or ramped up to the prescribed pressure, at which time a constant prescribed pressure is applied to the patient during both inspiration and expiration to provide maximum therapy. The delay may be set to an estimated time required for the patient to fall asleep. The ramp for increasing the EPAP pressure may be linear or may be at other desired slopes, such as exponential. Also, the EPAP pressure may be maintained at a set low level for a set period of time before the EPAP pressure begins to ramp up to the level of the IPAP pressure.
In a modified embodiment, a CPAP system is provided in which the initial IPAP pressure also is reduced below the prescribed pressure, but to a pressure higher than the initial EPAP pressure. Both the IPAP and the EPAP pressures are gradually increased at programmed rates to the therapeutic pressure. The rates at which the IPAP and EPAP pressures are increased may be the same, or may be different, and may be selected based on the patient's needs. Optionally, delays may be provided before beginning the IPAP and EPAP pressures. In a further modified embodiment, both the IPAP and the EPAP pressures are initially set to the same lower pressure and the IPAP pressure is ramped up at a faster rate than the EPAP pressure so that the IPAP pressure reaches the prescribed therapeutic pressure before the EPAP pressure.
Various objects and advantages of the invention will become apparent from the following detailed description of the invention and the accompanying drawings.
Program controlled CPAP apparatus is well known in the art. CPAP apparatus is commercially available for treating obstructive sleep apnea and other abnormal sleep events. The apparatus is programmed to apply a prescribed positive airway pressure to a patient's respiratory system while the patient sleeps. In one form of the program controlled CPAP apparatus, the pressure is reduced for a period of time while the patient falls asleep. This apparatus may be controlled to initially apply a pressure to the patient's airway which is below the prescribed therapeutic pressure and to ramp up the pressure to the prescribed level over a set period of time. Alternately, the apparatus may maintain the initial low pressure for a first period of time and then ramp up the pressure to the prescribed level over a second period of time.
CPAP apparatus has also been operated in a bilevel mode. In this mode, the apparatus detects when the patient begins to inhale and when the patient begins to exhale, generally by monitoring changes in the mass air flow from the CPAP apparatus to the patient, or by monitoring changes in the air pressure applied to the patient as the patient breathes, or by monitoring changes in both air flow and pressure. The apparatus is programmed to apply the prescribed therapeutic pressure (the IPAP pressure) when the patient inhales and to reduce the pressure when the patient exhales (the EPAP pressure). It is known that the bilevel CPAP apparatus may be started with the IPAP pressure set at or near the lower EPAP pressure, and that the IPAP pressure may be increased at a programmed rate to the prescribed pressure over a period of time while the patient falls asleep.
In both CPAP apparatus in which the IPAP and EPAP pressures are substantially the same and bilevel CPAP apparatus, during the initial reduced pressure startup period, the prescribed therapeutic pressure is not applied during the startup period. Nor are the IPAP pressure and the EPAP pressure optimized for the specific needs of the patient.
The invention is directed to methods for controlling the IPAP and EPAP pressures during an initial period while a patient on CPAP therapy falls asleep to acclimate the patient to the prescribed pressure. The invention may be implemented by modifying programming which controls existing CPAP and bilevel CPAP apparatus.
The bilevel operation may be controlled in different ways. In normal bilevel operation, the applied pressure is increased in response to detecting inhalation and is decreased in response to detecting exhalation. According to one aspect of the invention, the prescribed IPAP pressure is set as the default pressure. The CPAP apparatus may be operated to detect only the inhalation to exhalation transition. In response to detecting exhalation, the pressure is reduced to the EPAP pressure for a set time interval before returning to the default IPAP pressure. If desired, the rate at which the pressure returns to the default pressure can be set as a defined function. Alternately, only the exhalation to inhalation transition may be detected for increasing the applied pressure from the EPAP level to the IPAP level. After a preset time, the pressure can be returned to the EPAP level.
It will be appreciated that the highest IPAP pressure may be applied for only a portion of the patient's inspiration time and that the lowest EPAP pressure may be applied for only a portion of the patient's expiration time. Various modifications and changes may be made to the above described preferred embodiment of a method for acclimating a patient to CPAP therapy without departing from the scope of the following claims.
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|U.S. Classification||128/204.23, 128/204.26|
|International Classification||A61M16/00, A62B7/02, A61M16/06, A62B7/00|
|Cooperative Classification||A61M16/06, A61M2016/0024, A61M16/00, A61M16/0066|
|Jan 13, 2005||AS||Assignment|
Owner name: SUNRISE MEDICAL HHG INC., COLORADO
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNOR:KNEPPER, MICHAEL B.;REEL/FRAME:016179/0362
Effective date: 20050110
|May 14, 2009||AS||Assignment|
Owner name: DEUTSCHE BANK TRUST COMPANY AMERICAS, AS COLLATERA
Free format text: GRANT OF SECURITY INTEREST;ASSIGNOR:SUNRISE MEDICAL HHG INC.;REEL/FRAME:022678/0327
Effective date: 20090509
|Sep 7, 2010||AS||Assignment|
Owner name: DEVILBISS HEALTHCARE LLC, PENNSYLVANIA
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNOR:SUNRISE MEDICAL HHG, INC.;REEL/FRAME:024933/0862
Effective date: 20100621
|Apr 17, 2015||REMI||Maintenance fee reminder mailed|
|Apr 29, 2015||SULP||Surcharge for late payment|
|Apr 29, 2015||FPAY||Fee payment|
Year of fee payment: 4
|Jun 18, 2015||AS||Assignment|
Owner name: SUNRISE MEDICAL HHG INC., COLORADO
Free format text: RELEASE BY SECURED PARTY;ASSIGNOR:DEUTSCHE BANK TRUST COMPANY AMERICAS;REEL/FRAME:035859/0161
Effective date: 20150616
|Jul 2, 2015||AS||Assignment|
Owner name: GENERAL ELECTRIC CAPITAL CORPORATION, AS AGENT, MA
Free format text: SECURITY INTEREST;ASSIGNOR:DEVILBISS HEALTHCARE LLC;REEL/FRAME:035970/0001
Effective date: 20150702
|Nov 18, 2015||AS||Assignment|
Owner name: HEALTHCARE FINANCIAL SOLUTIONS, LLC, AS SUCCESSOR
Free format text: ASSIGNMENT OF INTELLECTUAL PROPERTY SECURITY AGREEMENT;ASSIGNOR:GENERAL ELECTRIC CAPITAL CORPORATION, AS RETIRING AGENT;REEL/FRAME:037129/0032
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